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Pharma & Biotech

CytoDyn touts publication of paper on suppression of human and simian immunodeficiency virus replication with leronlimab

The company said all five long-term patients “successfully” maintained HIV suppression through leronlimab monotherapy for over seven years, with no evidence of viral escape

CytoDyn Inc, a late-stage biotechnology company developing its flagship drug leronlimab for multiple indications, has revealed the publication of a peer-reviewed research paper on the suppression of human and simian immunodeficiency virus replication with the help of leronlimab.

The research paper titled “Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species” was published in the open-access PLOS Pathogens journal.

The Vancouver, Washington-based company said the study followed five human immunodeficiency virus (HIV) + human participants who, after successfully transitioning to once weekly subcutaneous leronlimab, halted their previous daily oral antiretroviral therapy regimens. These five participants came from an extension study, consisting of patients who were virologically suppressed in a prior study of leronlimab. Of the 10 patients enrolled in the extension study, four individuals experienced viral rebound and stopped leronlimab monotherapy, and one individual withdrew, leaving five long-term participants.

READ: CytoDyn submits the first of three main sections of its HIV Biologics License Application to FDA under rolling review

The company said all five long-term participants “successfully” maintained HIV suppression through leronlimab monotherapy for over seven years, with no evidence of viral escape. It is important to note that these five participants on leronlimab monotherapy exhibited a higher frequency (7.1%) of transient episodes of plasma viremia, termed viral blips, than those on combinational oral antiretroviral regimens (2.0%), said the company.

Meanwhile, to monitor the anatomical penetrance of leronlimab, rhesus macaques acutely infected with simian human immunodeficiency virus (SHIV) were treated with high intravenous doses of leronlimab for 12 weeks. Leronlimab treatment “reduced SHIV viral loads by 10,000-fold” and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, noted the biotech company.

In a statement, Jonah Sacha, the lead study author, who is a CytoDyn scientific advisor and an Oregon Health and Science University professor, said: “To our knowledge, these data represent the longest administration of monoclonal antibody monotherapy for HIV in people to date.”

CytoDyn is studying leronlimab in multiple areas, including infectious disease, cancer, and autoimmune conditions.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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